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Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3680
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials

§ 872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials.

(a) Identification. Polytetrafluoroethylene (PTFE) vitreous carbon material is a device composed of polytetrafluoroethylene (PTFE) vitreous carbon intended for use in maxillofacial alveolar ridge augmentation (building up the upper or lower jaw area that contains the sockets in which teeth are rooted) or intended to coat metal surgical implants to be placed in the alveoli (sockets in which the teeth are rooted) or the temporomandibular joints (the joint between the upper and lower jaws).

(b) Classification. Class II.

[52 FR 30097, Aug. 12, 1987; 52 FR 34456, Sept. 11, 1987]

Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3680
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials

§ 872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials.

(a) Identification. Polytetrafluoroethylene (PTFE) vitreous carbon material is a device composed of polytetrafluoroethylene (PTFE) vitreous carbon intended for use in maxillofacial alveolar ridge augmentation (building up the upper or lower jaw area that contains the sockets in which teeth are rooted) or intended to coat metal surgical implants to be placed in the alveoli (sockets in which the teeth are rooted) or the temporomandibular joints (the joint between the upper and lower jaws).

(b) Classification. Class II.

[52 FR 30097, Aug. 12, 1987; 52 FR 34456, Sept. 11, 1987]